Development & production of precursors
Once you have decided for a development candidate, we will be able to produce this compound under GMP. The whole GMP process is tailored according to the different phases of clinical development. A specification based on Ph. Eur. monograph 2902 will be drafted. We set analytical parameters and develop analytical procedures, which can be validated if necessary. Synthesis documents are prepared and refined, and master batch documents are established. GMP synthesis can be validated if required. All compounds are also tested in stability studies following ICH guidelines.